PACKAGE LEAFLET: INFORMATION FOR THE USER
Brufen 400 mg Effervescent Granules
Ibuprofen
The PL includes alternative texts for different legal status in different countries as follows:
- Boxed texts are only applicable for OTC versions
- Grey-shaded texts in brackets are only applicable for prescription versions.
[Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.]
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have
told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
You must talk to a doctor if you feel worse, or if you do not feel better after 3 days with fever
and 5 days with pain.
What is in this leaflet:
1.
2.
3.
4.
5.
6.
What Brufen is and what it is used for
What you need to know before you take Brufen
How to take Brufen
Possible side effects
How to store Brufen
Contents of the pack and other information
1.
WHAT BRUFEN IS AND WHAT IT IS USED FOR
Brufen belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’ or NSAIDs.
One sachet of medicine contains 400 mg of ibuprofen.
This medicine is for short-term use
 to relieve mild to moderate pain such as headache and toothache ,
 to relieve period pain

to reduce fever (high temperature)
It can be used in adults and adolescents over 12 years (40 kg and above).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN
Do not give/take Brufen:
 to children younger than 12 years of age
 if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section
6)
 if you have ever had an allergic reaction to ibuprofen, acetylsalicylic acid or other NSAIDs the signs include a reddening or rash of the skin, swollen face or lips, runny nose, wheezing or
shortness of breath
 if you have (or have had two or more episodes of) a stomach/duodenal ulcer (peptic ulcer) or
bleeding
 if you have ever had bleeding or a tear in your stomach or gut when taking NSAIDs
 if you have severe liver or kidney problems
 if you have severe heart failure or coronary heart disease
 if you are suffering from bleeding on the brain (cerebrovascular bleeding) or other active
bleeding
 if you have an illness that may make you more likely to bleed
 if you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient
fluid intake)
 if you are in the last 3 months of pregnancy. See ‘Pregnancy, breast-feeding and fertility’ below
for more information.
Do not take Brufen if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Brufen:
 if you have chronic inflammatory intestinal diseases such as inflammation of the colon with
ulcers (ulcerative colitis), inflammation affecting the digestive tract (Crohn’s disease) or other
stomach or intestinal diseases
 if you have disturbances in the formation of blood cells
 if you have problems with normal blood clotting mechanism
 if you suffer from allergies, hay fever, chronic swelling of nasal mucosa, sinuses, adenoids, or
chronic obstructive respiratory disorders, because the risk for developing narrowing of the
airways with difficulty in breathing (bronchospasm) is greater. There is also an increased risk of
allergic reactions occurring, which may present as asthma attacks, swelling of the skin or hives.
 if you have ever had asthma
 if you suffer from circulation problems in the arteries of your arms or legs
 if you have liver, kidney, heart problems or high blood pressure
 if you have just had major surgery
 if you are in the first six months of pregnancy
 if you are planning a pregnancy (see ”Pregnancy, breast-feeding and fertility” below for more
information)
 if you are breast-feeding
 if you have chickenpox
 if you have Systemic Lupus Erythematosus (SLE) or other autoimmune diseases
 if you have inherited a disorder of the red blood pigment haemoglobin (porphyria)
Talk to your doctor or pharmacist before taking Brufen if any of the above apply to you.
Elderly
Elderly people should be aware of their increased risk of adverse events, especially bleeding and
perforation in the digestive tract, which may be fatal.
Lowest effective dose
The lowest effective dose should always be used to minimise the risk for adverse events. Using a
higher dose than recommended may cause serious risks.
With Brufen, there is a risk of serious side effects. Please refer to section 4 for information on
what action to take if this occurs.
Heart attack and stroke
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased
risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended
dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Brufen if you:
- have heart problems including heart failure, angina (chest pain), or if you have had a heart
attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to
narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient
ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or
stroke, or if you are a smoker.
Renal effects
There is a risk of kidney damage in dehydrated adolescents and the elderly.
Children under 12 years of age
This medicine should not be given to children under 12 years of age.
Other medicines and Brufen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This is because Brufen can affect the way some other medicines work. Also, some other
medicines can affect the way Brufen works.
Brufen may affect or be affected by some other medicines. For example:
 acetylsalicylic acid
 Do not use this medicine if you are taking other NSAID painkillers.
 other medicines containing ibuprofen, such as those you can buy without a prescription
 medicines for heart problems - such as digoxin
 medicines for diabetes (so-called sulphonylureas)
 medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine)
 medicines that suppress your immune system - such as ciclosporin or tacrolimus
 medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers
such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
 diuretics (water tablets)
 steroids - used for inflammatory conditions
 selective serotonin reuptake inhibitors (SSRIs) - used for depression
 some antibiotics for infections - including aminoglycosides and quinolones
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zidovudine - used for HIV or AIDS
methotrexate - used for some cancers
cholestyramine - used to lower cholesterol
lithium - used for some forms of depression
voriconazole or fluconazole - used for fungal infections
mifepristone - used for medical termination of pregnancy
Ginkgo biloba – a herbal medicine often used in dementia
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before
taking Brufen.
Some other medicines may also affect or be affected by the treatment of Brufen. You should
therefore always seek the advice of your doctor or pharmacist before you use Brufen with other
medicines.
Brufen with alcohol
If you drink alcohol whilst taking this medicine, you may be more likely to get side effects.
Pregnancy, breast-feeding and fertility
Pregnancy
 Do not take this medicine if you are in the last 3 months of pregnancy.
 Talk to your doctor or pharmacist before taking this medicine if you are planning a pregnancy,
or are in the first 6 months of pregnancy. You should only take this medicine on the advice of
your doctor.
Breast -feeding
Ibuprofen is excreted in breast milk but is not likely to have an effect on the infant. Consult a doctor
if you use Brufen more often than temporarily while breast-feeding.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This
effect is reversible on stopping the medicine. It is unlikely that ibuprofen, used occasionally, will
affect your chances of becoming pregnant, however, tell your doctor or pharmacist before taking
this medicine if you are having problems getting pregnant.
Driving and using machines
This medicine may make you feel dizzy or sleepy. If this happens, do not drive or use any tools or
machines. Do not do anything else where you need to be alert.
Brufen contains sucrose
Sucrose is a sugar. If you have been told by your doctor that you cannot tolerate or digest some
sugars, talk to your doctor before taking this medicine.
Brufen contains sodium
Brufen contains 100 mg sodium per sachet. This should be taken into account if you are on a low
sodium diet. You may need to have less sodium in your diet because of the sodium in this medicine.
3.
HOW TO TAKE BRUFEN
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The product is intended for short-term use only. You should take the lowest dose for the shortest time
necessary to relieve your symptoms.
How much to take
Adults and adolescents over 12 years of age (40 kg or above)
Take one sachet (400 mg) as a single dose or up to 3 times a day with an interval of 4 to 6 hours.
More than 400 mg at a time does not give a better analgesic effect.
Do not take more than a total of 3 sachets (1200 mg) in any 24 hours.
People with liver or kidney problems
If you have liver or kidney problems, your doctor will tell you the correct dose to take. This will be
the lowest dose possible.
The elderly (over 65 years)
If you are elderly, your doctor will tell you the correct dose to take. This will be the lowest dose
possible.
Taking this medicine
In order to achieve a faster onset of action, the dose may be taken on an empty stomach. If you have
a sensitive stomach, take the dose with food.
 Empty the granules from one sachet into a small glass of water (about 125 ml).
 Make sure that you use all of the granules in the sachet.
 Stir the medicine until it stops bubbling and the granules have dissolved - this will make an
orange flavoured, fizzy drink.
How long to continue treatment
If symptoms worsen, or do not improve within 3 days with fever and 5 days with pain consult your
doctor.
If, in adolescents, aged 12-18 years, symptoms worsen, or if this product is required for more than 3
days, a doctor should be consulted.
If you take more Brufen than you should
If you have taken more of this medicine than you should, contact a doctor or go to the nearest
hospital straight away. Take the medicine pack with you.
The signs of an overdose can include: feeling sick, stomach pain, being sick (may have blood in it),
headache, ringing in the ears, confusion and shaky eye movement. At high doses, there may be loss
of consciousness, fits (mainly in children), feeling weak or dizzy, blood in the urine, feeling cold
and breathing problems.
If you usually take painkillers, especially combinations of different substances with painkilling
effect, you may damage your kidneys permanently, with the risk of kidney failure. This risk may be
increased if you are dehydrated. Therefore you should avoid excessive use of any painkillers.
If you use painkillers for a long time, this can cause headaches, which should not be treated with
more painkillers. If you think this applies to you, talk to your doctor or pharmacist.
If you forget to take Brufen
 If you forget a dose, take it as soon as you remember. However, if it is nearly time for your
next dose, skip the missed dose.
 Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking this medicine and see your doctor straight away if you notice any of the following
serious side effects - you may need urgent medical attention:
Common (may affect up to 1 in 10 people):
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Black tarry stools (faeces/motions) or blood in the stools

Vomiting any blood or dark particles that look like coffee grounds
Very rare (may affect up to 1 in 10,000 people):

Swelling of the face, tongue or throat (larynx) which can cause great difficulty in breathing
(angioedema), rapid heartbeat, severe fall in blood pressure or life threatening shock

A sudden allergic reaction with shortness of breath, wheezing and drop of blood pressure

Severe rash with blisters on the skin, especially on the legs, arms, hands and feet which can
also involve the face and lips (erythema multiforme, Stevens-Johnson syndrome). This can
get even more severe, where the blisters get larger and spread out and parts of the skin may
slough off (toxic epidermal necrolysis). There may also be severe infection with destruction
(necrosis) of skin, subcutaneous tissue and muscle.
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Disorders of blood cell formation (agranulocytosis, with symptoms like fever, sore throat,
surface mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding). Your
doctor will need to check the amount of blood cells in your blood.
Stop taking this medicine and see your doctor straight away if you notice any of the side effects
above.
Stop taking this medicine and tell your doctor if you notice any of the following:
Common (may affect up to 1 in 10 people):

Heartburn, abdominal pain, indigestion
Uncommon (may affect up to 1 in 100 people):

Blurred vision or other eye problems

Hypersensitivity reactions such as hives, skin rash, itching, asthma attacks (sometimes with
low blood pressure)
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Sensitivity to light
Rare (may affect up to 1 in 1,000 people):

Vision loss
Very rare (may affect up to 1 in 10,000 people):
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Sudden filling of lungs with water resulting in difficulty to breathe, high blood pressure,
water retention and weight gain
Stop taking this medicine and tell your doctor if you notice any of the side effects above.
Other side effects
Common (may affect up to 1 in 10 people):

Disturbances in the digestive tract, such as diarrhoea, feeling sick, vomiting, wind,
constipation
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Headache, sleepiness, dizziness, agitation, insomnia, irritability, vertigo

Microscopic bleeding from the intestine which may result in anemia
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Tiredness
Uncommon (may affect up to 1 in 100 people):
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Digestive tract ulcer with or without perforation
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Complications of diverticula of the large bowel (perforation or fistula)
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Mouth ulcers and inflammation
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Inflammation of the stomach lining
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Runny nose
Difficulty breathing (bronchospasm)
Anxiety
Pins and needles
Difficulty hearing
Asthma
Acute inflammation of the liver, yellowish discolouration of the skin or whites of the eyes,
liver dysfunction
Rare (may affect up to 1 in 1,000 people):
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Depression, confusion, hallucinations
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Lupus erythematosus syndrome
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Liver damage
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Oedema
Very rare (may affect up to 1 in 10,000 people):

Unpleasant awareness of heart beat, heart failure, heart attack or high blood pressure
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Ringing or buzzing in the ears
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Inflammation of the oesophagus or pancreas
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Narrowing of the bowel
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Liver failure
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Inflammation of the brain membrane (without bacterial infection)
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Damage of the kidney tissue
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Kidney problems including inflammation of the kidneys and kidney failure
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Hair loss
Not known (we do not know how often these happen)
 Burning feeling in the throat or mouth, this may happen briefly after taking this medicine
 Worsening of ulcers in the large intestine and Crohn’s disease (bowel disease)
The following side effects have also been reported with other NSAIDs:
 High blood pressure or heart failure
 A small increased risk of heart attack or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects (see details below). By reporting side
effects you can help provide more information on the safety of this medicine.
To be completed nationally
5.
HOW TO STORE BRUFEN
Keep out of the sight and reach of children.
Store below 25C. Store in the original package in order to protect from light and moisture.
Do not use this medicine after the expiry date stated on the sachet and carton. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Brufen contains
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The active substance is ibuprofen. One sachet contains: ibuprofen 400 mg.
The other ingredients are malic acid, saccharin sodium, sucrose, povidone, orange flavour,
sodium laurilsulfate, sodium hydrogen carbonate and anhydrous sodium carbonate.
What Brufen looks like and contents of the pack
Brufen is a white powder with an orange flavour. Your medicine will be contained in sachets.
Each pack contains 12, 15, 20, 30 or 40 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
<To be completed nationally>
Manufacturer:
AbbVie S.r.l., S.R. 148 Pontina km 52 snc, 04011 Campoverde di Aprilia (LT), Italy
This medicinal product is authorised in the Member States of the EEA under the following
names:
Sweden
Austria
Belgium
Bulgaria
Czech Republic
Estonia
Spain
Hungary
Ireland
Italy
Lithuania
Luxembourg
Latvia
Netherlands
Poland
Portugal
Romania
Slovenia
Slovakia
UK
Brufen 400 mg brusgranulat
Brufen 400 mg Brausegranulat
Brufen Granules 400 mg
Brufen 400 mg Effervescent Granules
Brufedol 400 mg šumivé granule
Brumare
Dalsy 400 mg granulado efervescente
Brufen 400 mg pezsgőgranulátum
Brufen 400 mg Effervescent Granules
FROBEN DOLORE E INFIAMMAZIONE
Brumare 400 mg šnypščiosios granulės
Brufen Granules 400 mg
Brumare 400 mg putojošās granulas
Brufen 400 mg bruisgranulaat
Abfen Forte
Brufen 400 mg granulado efervescente
Abfen 400 mg granule efervescente
Brufen Gran 400 mg šumeča zrnca
Brufedol 400 šumivý granulát
Brufen 400 mg Effervescent Granules
This leaflet was last revised in 2015-11-25